Stephan O. Krause, PhD
AstraZeneca Biologics
Director of QA Technology
Dr. Stephan O. Krause is AstraZenca's Director of QA Technology in clinical/commercial biologics operations. Prior to that, he was in MedImmune's Regulatory Science group (headquarters). Other previous roles include Director of QC, Manager of QA/QC Technical Services and compendial liaison at Bayer Biologics.
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Stephan often chairs and/or provides talks at major conferences, most recently he co-chaired the PDA/FDA Biosimilar conference. He is a frequent and recognized author. He won the Fred Simon award in 2017 and PDA’s distinguished book award in 2008. Stephan is the primary author and task force leader of PDA TR 57 (2012). He is co-author of PDA TR 65 for Technology Transfer (2014), PCMO's task force leader for IMP Specification Setting (2015), and the Biosimilars Initiative co-leader. He is a member of PDA's Biotechnology Advisory Board, Education Advisory Board, and a PDA trainer (TRI member).
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Stephan was nominated to PDA' Board of Directors (2017-19). In recent years, he was invited by OBP/CDER/FDA and presented multiple times to the OBP CMC reviewers (at FDA headquarters) an industry perspective.
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Stephan often chairs and/or provides talks at major conferences, most recently he co-chaired the PDA/FDA Biosimilar conference. He is a frequent and recognized author. He won the Fred Simon award in 2017 and PDA’s distinguished book award in 2008. Stephan is the primary author and task force leader of PDA TR 57 (2012). He is co-author of PDA TR 65 for Technology Transfer (2014), PCMO's task force leader for IMP Specification Setting (2015), and the Biosimilars Initiative co-leader. He is a member of PDA's Biotechnology Advisory Board, Education Advisory Board, and a PDA trainer (TRI member).
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Stephan was nominated to PDA' Board of Directors (2017-19). In recent years, he was invited by OBP/CDER/FDA and presented multiple times to the OBP CMC reviewers (at FDA headquarters) an industry perspective.